BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 22214213 · Received June 16, 2025

    Report

    Report Number
    9610595-2025-11312
    Event Type
    Malfunction
    Date Received
    June 16, 2025
    Report Date
    December 12, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    PMA / PMN Number
    K192793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE COMPLETED INVESTIGATION'S REVIEW OF THE CUSTOMER CLEANING DISINFECTION AND STERILIZATION (CDS) PROCESSES, THE DEVICE EVALUATION AND THE FINAL INVESTIGATION. UPDATED FIELDS: B5; B6; D8; G1; G3; H2; H3; H4; H6 AND H11. CORRECTED FIELD: E1. THIS REPORT IS RELATED TO 9610595-2025-11318 (2/3). THE DEVICE WAS CULTURE TESTED POSITIVE BY THE CUSTOMER. OLYMPUS PROVIDED THE FOLLOWING RESULT OF THE CULTURE TEST, BY THE CUSTOMER: SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: UNKNOWN. CFU: UNKNOWN. BACTERIAL IDENTIFICATION: ENTEROCOCCUS FAECALIS. SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: UNKNOWN. CFU: UNKNOWN. BACTERIAL IDENTIFICATION: NO GROWTH. SAMPLING DATE: (B)(6) 2025. SAMPLING FROM: UNKNOWN. CFU: UNKNOWN. BACTERIAL IDENTIFICATION: ENTEROCOCCUS FAECIUM; ENTEROCOCCUS GALLINARUM. SAMPLING DATE: (B)(6) 2025. SAMPLING FROM: SCOPE. CFU: UNKNOWN. BACTERIAL IDENTIFICATION: NO GROWTH AFTER SEVEN DAYS. THE DEVICE WAS EVALUATED WHERE NO ABNORMALITIES WERE FOUND THAT COULD HAVE LED TO THE REPORTED EVENT. BASED ON THE RESULTS OF THE INVESTIGATION, THE USER REQUEST WAS CONFIRMED, AND A ROOT CAUSE COULD NOT BE DETERMINED. GROWTH OF MICROORGANISMS WERE FOUND THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. THE DEVICE INSPECTION REPORT DIDN'T CONTAIN CRITICAL DEVIATIONS WHICH COULD CONTRIBUTE TO THE CUSTOMER¿S FINDINGS. WITHOUT THE CDS INFORMATION FROM THE CUSTOMER, OLYMPUS CANNOT CORRELATE ANY POSSIBLE LAPSES IN REPROCESSING REGARDING THE VALIDATED PROCEDURE DESCRIBED IN THE INSTRUCTIONS FOR USE (IFU) WITH PRODUCT STATUS. CUSTOMER PERFORMED ENHANCED CLEANING PROCEDURES, WHICH EVENTUALLY RESULTED IN A NEGATIVE HMI RESULT. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE WAS NOT ESTABLISHED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FLEX VIDEO SCOPE TESTED POSITIVE FOR KLEBSIELLA PNEUMONIAE AND ESCHERICHIA COLI. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE POST REPROCESSING. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING REPROCESSING, THE COLONOVIDEOSCOPE, IN (B)(6) 2024, TESTED POSITIVE FOR UNKNOWN COLONY FORMING UNITS (CFUS) OF ENTEROCOCCUS FAECALIS. THE DEVICE WAS RETESTED IN (B)(6) 2024, AND IT TESTED NEGATIVE. THE DEVICE WAS TESTED AGAIN IN (B)(6) 2025 AND TESTED POSITIVE FOR AN UNKNOWN CFUS OF ENTEROCOCCUS FAECIUM AND ENTEROCOCCUS GALLINARUM. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977209 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-HQ190L

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown